MAUDE Adverse Event Report: CORDIS CORPORATION SABER 4MM10CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48004010S

Device Problem Burst Container or Vessel (1074)

Patient Problem Perforation of Vessels (2135)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82185630 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.Additional information is also pending, however, it will be submitted within 30 days upon receipt.

Event Description

The physician confirmed that the 4mm x 10cm x 90cm saber rapid exchange (rx) balloon catheter (bc) ruptured, the contrast medium was leaking from the blood vessels and there was also vascular rupturing.After that, hemostasis was achieved, and it was confirmed that vessel was blocked.This was a shunt percutaneous transluminal angioplasty (pta) case.The device was used to perform plain old balloon angioplasty (poba) three (3) times and the pressure was within its nominal pressure.There was residual stenosis so, the physician inflated saber to rated balloon pressure twice.At the second time (fifth time in total), s/he felt that the contrast medium had come off.Originally it was a defect of the chronic total occlusions (cto¿s) non-growing shunt, but it was the physician¿s impression that it was opened after performing the three poba and was occluded after the vascular rupture by balloon's rupture.Saber device ruptured in a lesion with no calcification and no vascular tortuosity.It was inflated within rated balloon pressure that was 18 atmospheric pressure (atm).The device will be returned for analysis.

Manufacturer Narrative

The physician confirmed that the 4mm x 10cm x 90cm saber rapid exchange (rx) balloon catheter (bc) ruptured, the contrast medium was leaking from the blood vessels and there was also vascular rupturing.After that, hemostasis was achieved, and it was confirmed that vessel was blocked.This was a shunt percutaneous transluminal angioplasty (pta) case.The device was used to perform plain old balloon angioplasty (poba) three (3) times and the pressure was within its nominal pressure.There was residual stenosis so, the physician inflated saber to rated balloon pressure twice.At the second time (fifth time in total), s/he felt that the contrast medium had come off.Originally it was a defect of the chronic total occlusions (cto¿s) non-growing shunt, but it was the physician¿s impression that it was opened after performing the three poba and was occluded after the vascular rupture by balloon's rupture.Saber device ruptured in a lesion with no calcification and no vascular tortuosity.It was inflated within rated balloon pressure that was 18 atmospheric pressure (atm).The device was returned for analysis.A non-sterile saber 4mm x 10cm 90 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon was observed burst near the proximal band, as received.Blood residues were observed inside the balloon.No other anomalies were observed.Per sem analysis on the balloon burst observed during the visual review, results showed that the balloon burst was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the rupture condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82185630 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ was confirmed through analysis of the returned device.Based on the information available for review, vessel characteristics of a chronically occluded vessel, along with balloon inflation five times likely contributed to the reported event.Multiple inflations with the same balloon in a highly resistant vessel may weaken the balloon material increasing the likelihood of rupture.Analysis revealed scratch marks adjacent to the balloon rupture on the outer surface of the balloon.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon, such as calcified spicules located on the lesion.Risks associated with angioplasty procedures include vascular dissection in this case (vascular rupture was specifically reported).These are well-known and extensively documented potential complications of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal plaque rupture during interventional procedures.Review of the available information suggests that these lesion characteristics and possibly procedural factors may have contributed to the balloon burst and vessel rupture.A calcified/resistant lesion can cause damage to the balloon and result in vessel damage during angioplasty.According to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.Complications related to the product include, but are not limited to abrupt vessel closure, additional intervention, acute myocardial infarction, allergic reaction (device, contrast medium and medications), amputation, arrhythmias, arteriovenous fistula, bradycardia, death, embolism, hematoma at puncture site, hemorrhage, hypotension / hypertension, inflammation/ infection/ sepsis, ischemia, necrosis, neurological events, including peripheral nerve injury, transient ischemic attack and/ or stroke, organ failure (single, multiple), pain, paralysis, potential for balloon burst and potential complications (rated burst pressure), potential for separation and potential complications (integrity to be checked before and after use), procedural complications: bleeding, hypotension, access site complications, pseudoaneurysm, renal failure, restenosis of the dilated vessel, thrombosis, vascular complications (e.G.Intimal tear, dissection, pseudoaneurysm, perforation, rupture, spasm, occlusion).The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER 4MM10CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10824987
• MDR Text Key: 217089188
• Report Number: 9616099-2020-04049
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069783
• UDI-Public: 20705032069783
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 48004010S
• Device Catalogue Number: 48004010S
• Device Lot Number: 82185630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1