MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Imamura, s., nishida, k., kawai, k.Et al.(2016).A rare case of rotablator driveshaft fracture and successful percutaneous retrieval of a trapped burr using a balloon and guideliner.Cardiovasc interv and ther, 32, 294-298.[(b)(4)].

Event Description

It was reported via journal article that the burr became stuck in the lesion and the shaft fractured.The left anterior descending artery (lad) showed 99 % stenosis with a delay in the proximal portion the middle part of the left circumflex artery (lcx) displayed chronic total occlusion with development of collaterals, and the right coronary artery (rca) showed 75 % stenosis in the proximal portion and 99 % stenosis in the middle portion with severe calcification.After insertion of an intra-aortic balloon pump via the left femoral artery, percutaneous coronary intervention for the lad was performed via the right femoral artery.After aspiration thrombectomy for the lad, a 3.5 mm 9 15 mm non- bsc stent was deployed in the lad, and recanalization of the lad was achieved.Although he received optimal medical treatment in the intensive care unit after pci, congestive heart failure gradually deteriorated.Therefore, percutaneous coronary intervention was performed for residual stenosis of the rca on hospital day 8.After the 7 fr non- bsc guiding catheter was engaged in the rca, a non-bsc wire was crossed into the distal rca, and pre-dilatation was performed using a 2.0 mm 9 12 mm non-bsc balloon.Intravascular ultrasonography (ivus) of the distal lesion was then attempted, although it was not possible to pass through the culprit lesion in the rca because of the stenosis, tortuosity, and severe calcification of the vessel, as was seen on previous coronary computed tomography it was, therefore, necessary to use a rotablator.The first guide wire was exchanged for a rota floppy guide wire.Although ablation with a 1.5-mm burr was attempted with a pecking motion at 200,000 rpm, the burr could not pass through rca.The wire was, therefore, replaced by an extra-support rota wire and the device still could not pass rca, and instead suddenly became trapped in rca during the procedure.Further, although the burr could be rotated, it did not move.Simple manual pulling back on the system did not achieve successful removal.A second 7fr non-bsc guide catheter was inserted through the left femoral artery, and another guide wire was crossed through the second guide catheter to the distal rca.A 2.0 mm 9 12 mm non-bsc balloon was inflated at the site of burr entrapment.Despite several attempts at inflation and pulling back of the rotablator system, the burr did not move at all, and a fracture of the driveshaft was noted at the site of burr junction, with only the rota burr and wire left behind in rca.The fractured driveshaft was then confirmed.Fortunately, since coronary flow was not compromised by the rota burr, percutaneous removal of the burr was attempted.After the non-bsc wire was once again advanced into the rca from the first guide catheter, an attempt was made to catch the rota burr using a snare wire from the first guide catheter to prevent fracture of the rota wire, which also proved unsuccessful.Then, a 6 fr non-bsc catheter was advanced from the first guide catheter up to the trapped burr to attempt a child-in-mother catheter technique.This too proved unsuccessful, since the burr failed to enter the non-bsc guide catheter.Next, a 2.75 mm 9 12 mm snon-bsc balloon was delivered from the first guide catheter distal to the entrapped burr and inflated; it was then pulled manually using the fogarty catheter technique, but only the balloon slipped past.Thereafter, a combination of these two techniques was attempted.A 2.75 mm 9 12 mm non-bsc balloon was placed just distal to the burr and inflated to a nominal pressure, following which the non-bsc guide catheter was advanced up to the rota burr from the first guide catheter.Then, the rota burr was held between the inflated balloon and the non-bsc guide catheter.Finally, a strong backup force was achieved, and by pulling up on the system, it was possible to remove the burr into the first guide catheter without any other complications.It took about 30 minutes to retrieve the rota burr including all the attempts.The procedure was completed with stenting and further ballooning.Post procedure, the patient had improved condition and was discharged from the hospital.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9245829
• MDR Text Key: 163982364
• Report Number: 2134265-2019-13075
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2019

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 Model Number: 3241
• Device Catalogue Number: 3241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2.75 MM 9 12 MM SAPPHIRE NC PLUS BALLOON; GUIDELINER; SION BLUE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR