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

Model Number	G09190
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, a performer mullins guiding sheath was advanced over an unspecified wire guide into a patient's anatomy.Procedure and insertion site were not provided.The physician felt resistance and decided to remove the performer mullins guiding sheath.Upon removal, the complaint device was "sheared" from the tip to "5cm up the shaft".No portion remained in the patient's anatomy.A second performer mullins guiding sheath was advanced over the guide wire and an unspecified balloon catheter was introduced through it.This sheath also "sheared" and was removed from the patient's anatomy along with the balloon catheter.No portion of this second complaint sheath remained in the patient's anatomy.The patient did not experience any adverse effects as a result of this occurrence both performer mullins guiding sheaths were from the same lot.Although requested, patient demographics and additional event details were not provided.
Event or Problem Description
Additional information was received 23apr2019 indicating a valve replacement procedure was being performed at the time of this event.The complainant is not sure where access was gained with the sheath, but reported it was contralateral placement.Other devices in use were a balloon and wire; however, no manufacturer information was provided.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, specifications, and visual inspection of the returned device was conducted during the investigation.Two sheaths were returned used and damaged.Both sheaths exhibited ruptures along the length of the tubing.Both devices were measured to be within specification for sheath outside diameter and sheath length.The sheath inside diameter could not be accurately measured due to the damage.The devices cannot be confirmed to be manufactured out of specification.The product ifu states the following in consideration of the reported failure mode: ¿warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ a review of the device history record showed no related nonconformance and no other complaints under this lot number at the time of this investigation.The product¿s design history file shows evidence of verifications in place to meet design requirements related to this failure mode.Compiling this information, nonconforming product is not suspected in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive conclusion could not be made.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 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 MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8281401
• Report Number: 1820334-2019-00234
• Device Sequence Number: 19346900
• Product Code: DYB
• UDI-Device Identifier: 00827002091900
• UDI-Public: (01)00827002091900(17)191202(10)7485228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 12/02/2019
• Device Model Number: G09190
• Device Catalogue Number: RCFW-9.0-38-75-RB-MTS
• Device Lot Number: 7485228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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: PREVIOUSLY STATED