MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749389420

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

It was reported that catheter tip detached.After stent implantation, the physician wanted to use atlantis¿ sr pro imaging catheter for final intravascular ultrasound (ivus).However, it was noted that the tip of the device became dislodged and misplaced.The tip of the device was no where in the body of the patient.The procedure was completed with another of the same device.There were no additional patient complications reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.Device analysis revealed that the product returned have kinks in the sheath assembly at 45.5 cm and 27.4 cm from the femoral marker to the distal end.Imaging window was separated at 101 cm from the femoral marker to the distal end.The entire section of the guide wire exit port to the distal tip of the catheter was missing.Impedance testing shows a good unit wave form.Image characterization testing was not performed due to the returned conditions of the catheter.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that catheter tip detached.After stent implantation, the physician wanted to use atlantis sr pro imaging catheter for final intravascular ultrasound (ivus).However, it was noted that the tip of the device became dislodged and misplaced.The tip of the device was no where in the body of the patient.The procedure was completed with another of the same device.There were no additional patient complications reported and the patient's status is stable.

• Brand Name: ATLANTIS? SR PRO
• Type of Device: CATHETER, INTRAVASCULAR, 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: 4327344
• MDR Text Key: 5210057
• Report Number: 2134265-2014-07679
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2015
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 16687925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2014
• 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
• Patient Age: 64 YR