MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY CATHETER, PERCUTANEOUS

Model Number 8575

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: return product consisted of a runway guide catheter and loose fm. Analysis of the tip, shaft and hub included microscopic and visual inspection. Inspection found no damage to the device. The returned foreign matter (fm) was tangled together and could not be measured accurately. The fm was identified as fluorocarbon fiber, which is consistent with ptfe lining.

Event Description

It was reported that foreign matter was present on the device. A model 6f runway jl3. 5 guide catheter was selected for use in a percutaneous coronary intervention (pci). During the procedure, when the physician inserted the guide catheter, there was a string like a nylon coming out of the guide catheter. The physician quickly pulled the guide catheter out from the radial. The procedure was completed with a different device. No patient complications were reported and the patient was stable post procedure.

• Brand Name: RUNWAY
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPO; noblestraat 10 14; oostrum lb 5807 GA; NL 5807 GA
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9929439
• MDR Text Key: 186696623
• Report Number: 2134265-2020-04348
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K033441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/12/2020
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060102873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial