MAUDE Adverse Event Report: MEDTRONIC, INC. IN.PACT 018; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number IPU06015013P

Device Problems Stretched (1601); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The balloon was being walked out of the patient.The deflated balloon got stuck in sheath and the catheter stretched so the whole system was removed to remove the balloon catheter from the sheath.

• Brand Name: IN.PACT 018
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 15462260
• MDR Text Key: 300356257
• Report Number: 15462260
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPU06015013P
• Device Lot Number: 0011236896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33945 DA
• Patient Weight: 64 KG