MAUDE Adverse Event Report: INTEGRA YORK, PA INC. GARRETT DILATOR 5-1/2 X 1.0MM; CARDIOVASCULAR GENERAL

Catalog Number 310396

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that the garrett dilator 5-1/2 x 1.0mm tip breaks off.The tip broke off in a patient.It is unknown it there was any patient injury or a delay in surgery.Additional request for information has been sent.

Event Description

N/a.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Root cause cannot be determined due to the lack of information received to perform a complete investigation.

• Brand Name: GARRETT DILATOR 5-1/2 X 1.0MM
• Type of Device: CARDIOVASCULAR GENERAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7857460
• MDR Text Key: 119813942
• Report Number: 2523190-2018-00116
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• PMA/PMN Number: K030788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310396
• Device Lot Number: 235458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1