MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? 018; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M001FG000240

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that the imaging catheter got stuck in stent and sheath detachment occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified external iliac artery.During a procedure for an atherosclerosis obliterans (aso), an atlantis¿ 018 imaging catheter was used to visualize the lesion.An intravenous ultrasound (ivus) was attempted after deployment of the epic¿ stent in the target lesion; however, the atlantis¿ 018 imaging catheter came into contact and got stuck at the edge of the stent.Hence, the imaging catheter was unable to be pushed or pulled.Consequently, during the attempts of resolving the issue, it was furthermore noted that the guide wire exit port of the imaging catheter was detached.The device successfully removed by means of a snare or forceps.The procedure was completed using a different device.No patient complications were reported and the patient¿s status is good.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that the unit returned has the hub missing and received a partial device with only a section of the sheath to the distal tip with a guidewire inserted and stuck in the distal tip.Fluid residues (possible blood) were observed inside of the distal tip assembly and inside of the imaging window.A gross damaged were observed in the guidewire exit port assembly.Multiples kinks were observed along the length of the imaging window and tip.Additionally, a kink was observed in the sheath assembly at 1.4 cm from femoral marker to the proximal end.Functional test cannot be performed based on the returned condition of the catheter.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 further reported that the target lesion located in the left external iliac artery is 120 mm in length and 9.0 mm in diameter.An epic¿ stent and a non-bsc stent were implanted after pre-dilatation was completed and post dilatation then followed using a sterling¿ balloon catheter.However, during the post dilatation procedure, the sterling¿ balloon catheter ruptured; thus, a non-bsc balloon catheter was then used in post dilating the target lesion.In order to visualize the specified lesion, an atlantis¿ 018 imaging catheter was used accordingly.It was then observed that the monorail lumen of the imaging catheter was short.Furthermore, the shaft portion of the device got bent during the procedure and consequently, the guide wire exit port of the imaging catheter got stuck in the stent.Strong resistance was then encountered during the attempts of removing the imaging catheter from the patient.And in order to resolve the issue, they dismantled the hub; removed the imaging core and inserted a non-bsc guide wire into the lumen of the imaging catheter.They tried to withdraw the imaging catheter, however, tip detachment occurred.

• Brand Name: ATLANTIS? 018
• 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: 4666258
• MDR Text Key: 21845317
• Report Number: 2134265-2015-02180
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K073623
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2016
• Device Model Number: M001FG000240
• Device Catalogue Number: FG000-24
• Device Lot Number: 17600011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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
• Treatment: BALLOON CATHETER:STERLING; GUIDEWIRE:ASAHI INTECC; STENT:EPIC, SMART, LUMINEXX; INFLATION DEVICE:MEDTORONIC; INTRODUCER SHEATH:TERUMO