MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: upon receipt of the sample, visual examination under a microscope was performed over the entire length of the catheter and returned guidewire.It was revealed the distal portion of the balloon was not present.The inner shaft was circumferentially torn at the 33.5 cm geomarker, separating it from the outer shaft.The distal half of the balloon was circumferentially torn from the proximal portion of the balloon.The guidewire was returned with the inner shaft from the 33.5 cm geomarker indicator to the distal tip.Both marker bands are missing and the inner shaft is extremely accordioned on the guidewire.The complaint was a material rupture, but the sample¿s condition rendered functional testing for material rupture impossible.The proximal portion of the balloon was examined for a material rupture, but one was never found.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record shows the lot was manufactured to specification.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed the damage to the balloon and damage to the inner shaft is associated with the health care professional (hcp) retracting the catheter from the patient by force.The inner shaft was torn and the balloon was torn.The patient underwent a cutdown of the internal iliac artery to have the distal portion of the balloon retrieved successfully by the hcp.The hcp believes the catheter was not fully deflated and became caught on calcification during retraction.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured after the health care professional (hcp) inflated the balloon three times.The hcp used a contralateral approach with a 6 french introducer sheath and an advantage glidewire.The target lesion morphology and pathway to the lesion was not calcified or tortuous.The lutonix dcb was prepared in the normal fashion and the balloon protector was removed without issues.The hcp advanced the lutonix dcb under negative pressure to the target lesion and successfully inflated the balloon for lesion treatment.The hcp then used the lutonix dcb for predilation at a different lesion location and inflated the dcb twice, with the last inflation pressure at 10 atmospheres.The previous two inflation pressures are unknown.On the third inflation, the balloon ruptured.The hcp believes the balloon did not deflate completely.During the removal of the balloon over the guidewire, the hcp believes the balloon became caught on calcification which caused the balloon to break away from the catheter.The catheter was removed from the patient with a portion of the inner shaft and the distal half of the balloon missing.The guidewire was removed with the inner shaft stuck to the guidewire.The hcp believed the catheter and the balloon were successfully removed through the introducer sheath.Patient access was maintained with the introducer sheath and the hcp finished treating the additional lesions with an additional lutonix dcb.The hcp performed post fluoroscopy images of the vessel to angiographically confirm the success of the procedure and no problems were believed to be seen at this time.Later that evening, the patient became worse.The on call physician found the patient clotted off.A cutdown was performed to retrieve the lodged balloon from the internal iliac artery.The remaining portion of the balloon and clotted material was successfully removed from the patient without complications.The facility returned the guidewire and the two pieces of the lutonix dcb for further evaluation, but not the distal balloon remnant.No adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 6073708
• Report Number: 3006513822-2016-00194
• Device Sequence Number: 18970198
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306(17)180228(10)GFAP2162
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFAP2162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention