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

Model Number	IPN000144
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem 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 or Problem 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.
Additional 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:
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11671740
• Report Number: 9680794-2021-00148
• Device Sequence Number: 16919073
• Product Code: DQY
• UDI-Device Identifier: 00801902001931
• UDI-Public: 00801902001931
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: IPN000144
• Device Catalogue Number: CL-07745
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1