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

Model 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	08/12/2014
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
Two input ps introducer sheaths were used during a cardiac ablation.Patient suffered anaphylaxis.There is a possibility that the patient was allergic to ethylene oxide used to sterilise the devices.
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: 7524988
• Report Number: 1220452-2018-00061
• Device Sequence Number: 16470087
• Product Code: DYB
• UDI-Device Identifier: 20643169014514
• UDI-Public: 20643169014514
• 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): 11/16/2018

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: 04/01/2017
• Device Model Number: 080011
• Device Catalogue Number: 080011
• Device Lot Number: 50804227
• 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: 05/18/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 60