MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SEMI-FINISHED KIT: 7FR PTD OTW CATH 65CM; CATHETER EMBOLECTOMY

Catalog Number PT-65709-C

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reported "we had an otw tretola basket fracture and break off during a avg thrombctomy.We snared the product out and no harm, thankfully, to patient." no patient injury, or consequence reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported "we had an otw tretola basket fracture and break off during a avg thrombctomy.We snared the product out and no harm, thankfully, to patient".No patient injury or consequence reported.The patient's condition is reported as fine.

• Brand Name: ARROW SEMI-FINISHED KIT: 7FR PTD OTW CATH 65CM
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10647995
• MDR Text Key: 210417997
• Report Number: 9680794-2020-00399
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• 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: 09/15/2020

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: No Information
• Device Catalogue Number: PT-65709-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK AMPLATZ. .025 WIRE; COOK AMPLATZ. .025 WIRE; COOK AMPLATZ. .025 WIRE
• Patient Outcome(s): Required Intervention