MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING BALLOON DILATATION CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK413

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2014

Event Type  Injury  

Event Description

(b)(4) clinical study.It was reported that during a peripheral treatment procedure, watermelon seeding was noted.In mar 2013, rutherford assessment was category 3.The patient was treated as an outpatient.The target lesion was classified as a tasc b lesion located in the distal left superficial femoral artery (sfa) with 80% stenosis and was 100mm long with a reference vessel diameter of 6mm.The target lesion was treated with pre-dilation and placement of a 7x119x130mm innova stent, with 0% residual stenosis following post-dilation.In (b)(6) 2014, the patient reported left ankle pain/wound and was instructed to present to clinic.3 days later, the patient presented for unscheduled visit with complaint of left ankle wound.The patient was diagnosed with non healing osteomyelitis.Ultrasound revealed significant in-stent restenosis in the left sfa.The patient was hospitalized for treatment.While treating the in-stent restenosis with a 6x80mm sterling balloon, there was a watermelon seeding noted in the proximal portion, which was treated with a 6x2mm cutting balloon.The event was considered to be resolved without residual effects and the patient was discharged.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: STERLING BALLOON DILATATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3632380
• MDR Text Key: 20264656
• Report Number: 2134265-2014-00462
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR