MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G07338
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.(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, a performer introducer was "broken/misshapen" and caused a small tear in the patient's artery.Reportedly, the damage was found from the package; however, was not observed by the scrub nurse until the physician used the device.The plastic was "broken/misshapen" where the dilator meets the sheath.The original procedure involved a cut-down; therefore, the torn artery was repaired using sutures.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information was received 09apr2020 noting that the vessel was damage when the introducer was being placed into the artery over the j.Wire for initial artery access.No transfusion was required, the primary suture repair was adequate.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Event summary: as reported, during an unspecified procedure, a performer introducer was "broken/misshapen" and caused a small tear in the patient's artery.Reportedly, the damage was found from the package; however, was not observed by the scrub nurse until the physician used the device.The plastic was "broken/misshapen" where the dilator meets the sheath.The patient¿s vessel was damaged when the introducer was being placed into the artery over the j wire for initial artery access.The original procedure involved a cut-down; the torn artery was successfully repaired using sutures.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation: evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One 7.0fr rcf introducer with the dilator was returned for investigation.There was biological matter throughout.The distal end of the sheath was split.A document-based investigation evaluation was performed.A review of the device history record shows no failure-related nonconformances.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.No gaps were discovered in the manufacturing instructions or quality control procedures for this device.Cook has concluded that appropriate controls are in place to detect this failure mode prior to distribution.Based on the information available, investigation has concluded that the cause of this event is a component failure without design or manufacturing deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9934452
• Report Number: 1820334-2020-00781
• Device Sequence Number: 754590
• Product Code: DYB
• UDI-Device Identifier: 00827002073388
• UDI-Public: (01)00827002073388(17)221125(10)10150208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2020

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: 11/25/2022
• Device Model Number: G07338
• Device Catalogue Number: RCF-7.0-38-J
• Device Lot Number: 10150208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 06/25/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/10/2020; 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention