MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP90620B0

Device Problem Device Damaged by Another Device (2915)

Patient Problem Hematoma (1884)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that vessel hematoma occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery(cia).A 2cm peripheral cutting balloon¿ was selected for use.After dilatation was performed, when the device was retrieved into a 7f non bsc introducer sheath, it was noted that the blade of the device cut the sheath and hematoma was noted on the femoral artery.Astriction was performed to stop further bleeding.The physician removed the balloon catheter and the sheath; however, the physician observed difficulties in retrieving the catheter into the sheath.Subsequently, the devices were removed and a new sheath was inserted.The balloon catheter was inspected outside the patient's body and it was noted that only one blade seemed to be rewrapped.A new sheath was inserted to complete the case.No further patient complications and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr.,eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated y mfr.: the device was returned for evaluation.The introducer sheath used was not returned.A 6fr introducer sheath was used.It was then noted that the device was unable to insert through the sheath due to the condition of the returned device.Balloon had been inflated as the folds were relaxed and were not re-folded.Blood was evident in the lumen of the device and on the balloon.The balloon was inflated to its rated burst pressure of 10 atmospheres using an encore inflation device to get a better view of the blades.All the blades were intact and no damage was observed.The blades were coated in dry blood.Negative pressure was applied and the balloon deflated without issue.A microscopic and visual examination of the returned device found no kinks or damage along the entire length of the shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that vessel hematoma occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery(cia).A 2cm peripheral cutting balloon" was selected for use.After dilatation was performed, when the device was retrieved into a 7f non bsc introducer sheath, it was noted that the blade of the device cut the sheath and hematoma was noted on the femoral artery.Astriction was performed to stop further bleeding.The physician removed the balloon catheter and the sheath; however, the physician observed difficulties in retrieving the catheter into the sheath.Subsequently, the devices were removed and a new sheath was inserted.The balloon catheter was inspected outside the patient's body and it was noted that only one blade seemed to be rewrapped.A new sheath was inserted to complete the case.No further patient complications and the patient's condition was stable.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5854873
• MDR Text Key: 51424046
• Report Number: 2134265-2016-07083
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2018
• Device Model Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Device Lot Number: 18928406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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 Outcome(s): Required Intervention