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

Model Number	G48004
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = lead tech.(b)(4).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.
Event or Problem Description
Upon return and initial evaluation of a returned device used for an angioplasty procedure on (b)(6) 2021, the distal solder connection of a wire included in the micropuncture transitionless stiffened cannula access set was broken, resulting in coil elongation.An event description has not been provided by the customer.Additional information has been requested, but is unavailable at this time.
Event or Problem Description
Additional information was received 01mar2021.The physician was accessing a fistula with the complaint device, reportedly via femoral access.It is unknown if the micro wire was manipulated or removed through the needle.
Additional Manufacturer Narrative
Summary of event: upon return and initial evaluation of a returned device used for an angioplasty procedure on (b)(6) 2021, the distal solder connection of a wire included in the micropuncture transitionless stiffened cannula access set was broken, resulting in coil elongation.Additional information was received 01mar2021.The physician was accessing a fistula with the complaint device, reportedly via femoral access.It is unknown if the micro wire was manipulated or removed through the needle.Investigation evaluation: reviews of the complaint history, device history record, drawing, dimensional verification, 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.From the device analysis, the broken solder and elongation was confirmed, but no additional damage was noted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, ifu and returned device, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.The product ifu states ¿do not attempt to insert or withdraw the wire guide and / or introducer if resistance is felt¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to the failure mode.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.

• 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
• MDR Report Key: 11358407
• Report Number: 1820334-2021-00368
• Device Sequence Number: 4170479
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049(17)231213(10)13627039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Device Lot Number: 13627039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1