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

Catalog Number	080011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	02/21/2018
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
It is reported that the patient suffered anaphylaxis during cardiac ablation.It is indicated that it is likely to be secondary to the input ps introducer sheaths used in the procedure.
Additional Manufacturer Narrative
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: 7586606
• Report Number: 1220452-2018-00071
• Device Sequence Number: 19188523
• Product Code: DYB
• UDI-Device Identifier: 00643169014510
• UDI-Public: 00643169014510
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2020
• Device Catalogue Number: 080011
• Device Lot Number: 51027028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 126