MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? PV; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number H749364560

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was reported that the guidewire punctured the catheter.During introduction for a venous intravascular ultrasound (ivus) procedure outside the patient's body, an atlantis¿ pv imaging catheter was used to visualize an unspecified lesion.When the physician were loading the atlantis¿ pv into the unspecified guidewire, it was noted that the guidewire punctured through the wire lumen of the atlantis¿ pv imaging catheter right before it came out of the catheter's hub.The procedure was completed with another of the same device.No patient involved.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Corrected manufacturer name from boston scientific - (b)(4) to boston scientific - (b)(4).Corrected mfg site name from boston scientific - (b)(4) to boston scientific - (b)(4).Device evaluated by manufacturer: the complaint device was returned for evaluation.Device analysis revealed that there is an open hole at the sheath assembly at 94.3 cm from distal end to proximal end, sheath looks bent in the section where the hole is located and fluid was leaking from an open hole at the sheath assembly when the catheter was flushed.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the guidewire punctured the catheter.During introduction for a venous intravascular ultrasound (ivus) procedure outside the patient's body, an atlantis⠐v imaging catheter was used to visualize an unspecified lesion.When the physician were loading the atlantis pv into the unspecified guidewire, it was noted that the guidewire punctured through the wire lumen of the atlantis pv imaging catheter right before it came out of the catheter's hub.The procedure was completed with another of the same device.No patient involved.

• Brand Name: ATLANTIS? PV
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4663231
• MDR Text Key: 19350061
• Report Number: 2134265-2015-02070
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Model Number: H749364560
• Device Catalogue Number: 36456
• Device Lot Number: 17454345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• 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