MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3850

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Event Description

It was reported that the device inner packaging was leaking air.The 90% stenosed target lesion was located in the left anterior descending artery.A 6mmx2.00mm wolverine cutting balloon was selected for use.Upon unpacking, it was noted that the inner package was leaking air.Device contamination was of concern and the device was not used.The procedure was completed with another of the same device.No complications were reported and the patient was stable.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The product was received in its packaging.A visual and tactile examination was performed on the device packaging.The blue closure strip on the outer box had been torn open.Inside was the inner pouch with the device packaged inside its protective coil tubing.An examination of the inner pouch identified that the pouch had been partially torn open.A microscopic examination of the partially opened tray found clear evidence of the tray seal.

Event Description

It was reported that the device inner packaging was leaking air.The 90% stenosed target lesion was located in the left anterior descending artery.A 6mmx2.00mm wolverine cutting balloon was selected for use.Upon unpacking, it was noted that the inner package was leaking air.Device contamination was of concern and the device was not used.The procedure was completed with another of the same device.No complications were reported and the patient was stable.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17181937
• MDR Text Key: 317904973
• Report Number: 2124215-2023-31227
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

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: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0030219180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male