MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G48004
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = phone:(b)(6) postal code: (b)(4) this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during placement of a peritoneal dialysis catheter, a micropuncture transitionless stiffened (mpis) cannula access set¿s wire unraveled and/or separated.After the initial puncture, the physician used the mpis needle to obtain access via ultrasound guidance.The wire was then advanced, using ultrasound guidance, and upon manipulation, a clicking sound was heard.The procedure was paused.Per the initial reporter, the wire was severed, and part of the device remained in the patient¿s body.It is unknown if the wire was pulled backwards through the needle.The wire was close to the skin and therefore, an incision of ¿several centimeters¿ was made, and the remaining wire was removed.The procedure was completed using another device of the same type.Additional information provided by the customer indicated that the wire may have not separated, but rather unraveled/stretched.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional/corrected information: b5, d9, h6 (annex a), h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 04jun2024.The user attempted to remove the wire through the access needle included in the set.A photo provided by the customer shows the unraveled wire inside of the access needle.The wire did not separate.Nothing remained in the patient.It is unknown if the package was damaged.Details of the anatomy are unknown, and it is unknown if resistance was encountered during insertion or removal of the device.It is unknown if the wire was altered prior to use or if the inserter was used during insertion of the wire into the needle hub.
Additional Manufacturer Narrative
Summary of event: as reported, during placement of a peritoneal dialysis catheter, a micropuncture transitionless stiffened (mpis) cannula access set¿s wire unraveled and/or separated.After the initial puncture, the physician used the mpis needle to obtain access via ultrasound guidance.The wire was then advanced, using ultrasound guidance, and upon manipulation, a clicking sound was heard.The procedure was paused.Per the initial reporter, the wire was severed, and part of the device remained in the patient¿s body.It is unknown if the wire was pulled backwards through the needle.The wire was close to the skin and therefore, an incision of ¿several centimeters¿ was made, and the remaining wire was removed.The procedure was completed using another device of the same type.Additional information provided by the customer indicated that the wire may have not separated, but rather unraveled/stretched.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 04jun2024.The user attempted to remove the wire through the access needle included in the set.A photo provided by the customer shows the unraveled wire inside of the access needle.The wire did not separate.Nothing remained in the patient.It is unknown if the package was damaged.Details of the anatomy are unknown, and it is unknown if resistance was encountered during insertion or removal of the device.It is unknown if the wire was altered prior to use or if the inserter was used during insertion of the wire into the needle hub.Corrected information: d4.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The wire, which was returned lodged inside the access needle, had started to unravel at the solder joint.The wire separated during table-top testing at cook.The needle was not damaged.A document-based investigation evaluation was performed.A review of the device history record found two relevant non-conformances on seven devices from sub-assembly lots; however, all affected product was scrapped.A review of complaint history found no additional relevant complaints for this lot number.The product ifu states that the device is intended to be used in the peripheral vascular system.The ifu states ¿caution: do not withdraw the wire guide through the introducer needle; breakage may result.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although two relevant non-conformances were noted on sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that failure to follow instructions contributed to this event.The device was used for percutaneous access into the peritoneal cavity, and the user attempted to remove the wire through the access needle.The ifu states that the device is intended to be used in the peripheral vascular system, and cautions ¿do not withdraw the wire guide through the introducer needle.¿ the risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19361585
• Report Number: 1820334-2024-00697
• Device Sequence Number: 11725351
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049(17)260626(10)15505773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Device Lot Number: 15505773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 07/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/13/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HAYASHIDERA CAPD CATHETER JB-5 SWAN NECK SENDAI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown