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

Model Number	G35550
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
As reported, during an unspecified procedure via femoral access, half of the dilator included in a micropuncture transitionless stiffened cannula access set separated in the patient upon removal of the device.The access site was normal, and resistance was not reported during insertion or removal of the device.No ancillary devices were used with the set.Kinking was not noted.Access was lost when the dilator separated.The patient was transported to another facility and a cut-down surgical procedure was performed to retrieve the separated portion of the dilator.The surgeon reported that upon cut-down, it was discovered that the complaint device had "knicked" a metal clip from another manufacturer's previously placed closure device, causing the separation.The surgeon reported that the separation was not a defect of the complaint device.The patient is reportedly stable.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an unspecified procedure via femoral access, half of the dilator included in a micropuncture transitionless stiffened cannula access set separated in the patient upon removal of the device.The access site was normal, and resistance was not reported during insertion or removal of the device.No ancillary devices were used with the set.Kinking was not noted.Access was lost when the dilator separated.The patient was transported to another facility and a cut-down surgical procedure was performed to retrieve the separated portion of the dilator.The surgeon reported that upon cut-down, it was discovered that the complaint device had "knicked" a metal clip from another manufacturer's previously placed closure device, causing the separation.The surgeon reported that the separation was not a defect of the complaint device.The patient is reportedly stable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, manufacturing instructions, quality control data, and specifications.One used device was received.Inspection found the outer catheter has been separated.Only 4.5cm of material remained on the fitting.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.A capa was previously opened in response to a high number of complaints associated with this failure mode.The capa was closed at the root cause phase.Risk benefit analyses were performed for rpns in scope of the capa.The rbas concluded that the benefits of using the device outweigh the risks.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Although a definitive cause could not establish, a possible cause can be attributed to the procedure as the physician reported that "upon cut down it was determined that the micropuncture dilator knicked a metal clip from a previously placed star closure device and the broken dilator was thus the effect of this and not related to the cook product".Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 10762002
• Report Number: 1820334-2020-01984
• Device Sequence Number: 14286358
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)230927(10)13454865
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 09/27/2023
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 13454865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STAR CLOSURE DEVICE; STAR CLOSURE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention