MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; BALLOON WEDGE PRESSURE

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the guidewire 0.035" (non-teleflex) was used by the hospital", which is always used, did not pass through the lumen of the wedge pressure catheter, the used product with guidewire will be sent".A new catheter with another lot was successfully used.There was no report of delay in therapy or patient complications.

Event Description

It was reported that "the guidewire 0.035" (non-teleflex) was used by the hospital", which is always used, did not pass through the lumen of the wedge pressure catheter, the used product with guidewire will be sent".A new catheter with another lot was successfully used.There was no report of delay in therapy or patient complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of guidewire "did not pass through the lumen of the wedge pressure catheter" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: BALLOON WEDGE PRESSURE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9225197
• MDR Text Key: 183175270
• Report Number: 3010532612-2019-00379
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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 Model Number: N/A
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F19B0087
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1