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

Model Number	G08957
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other healthcare professional.Pma/510(k) number: pre-amendment.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
It was reported, there was a puncture in the performer introducer.A (b)(6) male weighing (b)(6) was undergoing a "watchmen" left atrial appendage closure procedure.Access was gained via the left femoral artery.The patient's anatomy was neither scarred, calcified, or angled.At the time of the event, the complaint device had been in place approximately two hours.Other devices used at the time of the event were 14fr watchmen device, 14fr watchmen sheath, 8.5fr unspecified transseptal needle and sheath.Reportedly, extra per close devices were required.No blood loss has been reported.The procedure was successfully completed without any patient adverse effects.No additional event details were provided regarding the reported "puncture" in the performer introducer.No additional procedures were required.A portion of the device did not remain in the patient's anatomy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one rcfw-14.0-38-30-rb device with the dilator inserted through the proximal hub was returned for investigation.There was visible biological matter on the hub.The sheath tubing was kinked 6.3cm from the proximal hub.At 9.1cm from the hub, the tubing was punctured and deformed.There was no additional surface damage on the sheath, and the dilator was undamaged.The customer did provide two photos, one of the product label and the second of the punctured section of the device.Cook also review the wire guide manufacturer¿s specifications and confirmed that both diameters could be advanced through the 14 fr inner diameter cook sheath.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the quality control procedures and overall device master record were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device which states precautions: when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and the examination of the returned product, investigation has concluded that the customer did not notice the puncture until after the procedure was completed, indicating that the failure occurred while the device was inside the patient.The hole in the material did not appear to be caused by a kink or by a device malfunction, but by an ancillary device.It is likely that the puncture was caused by either the watchman device, or by the transseptal needle used to treat the patient.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.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.
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: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8475430
• Report Number: 1820334-2019-00741
• Device Sequence Number: 1515260
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)211203(10)9291872
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 05/21/2019

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: 12/03/2021
• Device Model Number: G08957
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Device Lot Number: 9291872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 115