MAUDE Adverse Event Report: MEDTRONIC, INC INPUT PS INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	080011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An 8f input introducer was attempted to be used.No damage noted to packaging.No issues removing the device from the packaging.The device was inspected and prepped per ifu without issue.No resistance was noted when attempting to remove the introducer from the sheath.No resistance was encountered when inserting the dilator into the sheath during prep.It is reported that the sheath of the device cracked at the end of the procedure, as the operator was pulling back the device.The device was not bent excessively prior to the detachment.A portion of the device remained in the artery.A surgeon was called to remove the remaining piece of the device from the artery.The piece was successfully removed from the patient.No further injury reported.
Additional Manufacturer Narrative
Image review: a photograph of the device shows the proximal portion of a bloody input introducer with the sheath cut at an angle approx.1.5cm from the hub.This was consistent with the returned device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: cine image provided by the customer shows the cut end of the sheath in the anatomy.Product analysis summary: as received the sheath is cut in two approximately 1.5cm from the hub and the sheath is wrinkled and kinked, and the very distal edge/tip of the sheath is creased/damaged.None of the sheath is missing, full length is accounted for and none of the tip appears to be missing, just damaged.The cut in the sheath was more than ¾ way through, the remaining material that was still attached was stretched and pulled and broke, separating the proximal sheath from the hub.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INPUT PS INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8003684
• Report Number: 1220452-2018-00125
• Device Sequence Number: 1105187
• Product Code: DYB
• UDI-Device Identifier: 00643169014510
• UDI-Public: 00643169014510
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K132617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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: 08/13/2020
• Device Catalogue Number: 080011
• Device Lot Number: 51030302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 03/06/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/07/2019; 03/06/2019
• 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
• Patient Age: 56 YR