MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THREADER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1860
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an fg threader mr 1.2mm x 12mm catheter.Device was received inside boxed packaging and pouch; however, pouch seal was broken, and carton was taped closed with tape.Visual observation of the device identified that shaft separation at 129.5 cm from the strain relief.The distal inflation lumen from the separation point was missing from the returned device.Numerous kinks were identified on the hypotube.Product analysis confirms the reported event as balloon, distal tip, and inflation lumen from the separation point was identified missing.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that a device component was missing.Upon unpacking of a 1.2mm x 12mm threader balloon catheter, it was noticed that the balloon was missing.There were no patient complications reported.However, returned device analysis revealed a shaft detached/separated.

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15914767
• Report Number: 2124215-2022-50495
• Device Sequence Number: 15152942
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0027619886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG