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

Model Number	G07417
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a pulmonary valvuloplasty, approximately three (3) centimeters of the performer introducer broke and separated from the sheath inside of the patient.The sheath was placed in the patient's right femoral artery through the groin; another manufacturer's balloon was being utilized through the sheath during the event.The separated piece was not retrieved during the event.Further information regarding device retrieval status will be provided upon receipt of this information.According to the initial reporter, the patient has not experienced any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device noted a jagged edge on the distal portion of the device.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 be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7083409
• Report Number: 1820334-2017-04314
• Device Sequence Number: 1461343
• Product Code: DYB
• UDI-Device Identifier: 00827002074170
• UDI-Public: (01)00827002074170(17)200314(10)7674265
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G07417
• Device Catalogue Number: RCF-10.0-38-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 04/26/2018
• 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: Other
• Patient Age: 58 YR