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

Catalog Number 060011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Stroke/CVA (1770); Reaction (2414)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

Incorrect pma / 510(k) # was submitted in error.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The first sign of a stroke occurring was right arm weakness which was noted immediately in the recovery room.The patient was then transferred for ct angiography.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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9265316
• MDR Text Key: 164580445
• Report Number: 1220452-2019-00141
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169014657
• UDI-Public: 00643169014657
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K132617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: 060011
• Device Lot Number: 51031952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 91