MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET:; CATHETER PERCUTANEOUS

Model Number IPN000144

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "patient had a severely calcified profunda artery.Access a.Fem.Right, cossover with arrow sheath f7.The stenosis was difficult to overcome, but was successfully retrograded.Pre-dilatation of the stenosis and then with shockwave balloon 6.5 mm.Removal of the balloon to the sheath.The balloon cannot be pulled into the sheath.The arrow sheath and the shockwave balloon were removed together." the clinical consequence was reported as increased intervention time.No patient harm was reported.

Event Description

The complaint is reported as: "patient had a severely calcified profunda artery.Access a.Fem.Right ,cossover with arrow sheath f7.The stenosis was difficult to overcome, but was successfully retrograded.Pre-dilatation of the stenosis and then with shockwave balloon 6.5 mm.Removal of the balloon to the sheath.The balloon cannot be pulled into the sheath.The arrow sheath and the shockwave balloon were removed together." the clinical consequence was reported as increased intervention time.No patient harm was reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11671740
• MDR Text Key: 245603868
• Report Number: 9680794-2021-00148
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902001931
• UDI-Public: 00801902001931
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 03/25/2021

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 Model Number: IPN000144
• Device Catalogue Number: CL-07745
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1