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

Catalog Number	070011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Stroke/CVA (1770); Reaction (2414)
Date of Event	04/16/2019
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
Four input introducers sheaths were used during an electrophysiologic procedure.Two 6 fr sheaths, one 5 fr sheath and one 7fr sheath were placed without complication.It was reported that immediately after flushing the sheaths and introducing an electrophysiologic catheter the patient suffered an anaphylactoid reaction characterised by profound hypotension, tachycardia, distressed breathing and urticarial skin reaction.The patient was stabilized.Recovery was prompt and the patient proceeded to have the electrophysiologic procedure undertaken.Post procedure the patient had a stroke.The patient has since returned to work but has impairment to one arm.It was queried if the device contained latex as the hospital are trying to establish what caused the reaction.
Additional Manufacturer Narrative
The first sign of a stroke occurring was right arm weakness which was noted immediately in the recovery room.The patient has since returned to work but has impairment to one arm.The electrophysiologist assessed that the stroke was not directly related to the input sheath devices.However, it was assessed that it was possible that the anaphylactic reaction at the commencement of the procedure produced an activated coagulated state which increased the risk of embolic events.Ablation within the left atrium is accepted as a possible cause for cerebrovascular events.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: 9265328
• Report Number: 1220452-2019-00142
• Device Sequence Number: 11196296
• Product Code: DYB
• UDI-Device Identifier: 00643169014589
• UDI-Public: 00643169014589
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 11/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2020
• Device Catalogue Number: 070011
• Device Lot Number: 51033036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: 28 YR
• Patient Weight: 91