MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07126

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the catheter was inserted into the pulmonary vein, it was noted that the guide wire could not be passed through the lumen.As a result, the catheter was removed, and a new catheter was opened and used.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the catheter was inserted into the pulmonary vein, it was noted that the guide wire could not be passed through the lumen.As a result, the catheter was removed, and a new catheter was opened and used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of swg/catheter resistance is not confirmed.The returned devices passed functional test specifications.During functional testing, the guide wire loading tests were successful for all devices using a lab inventory 0.025in guidewire.The root cause of the complaint is undetermined.No further action required at this time.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8962313
• MDR Text Key: 156574991
• Report Number: 3010532612-2019-00307
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

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 Expiration Date: 06/30/2020
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F19B0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1